(70 days)
Expa-syl
Not Found
No
The device is a paste containing a hemostatic agent for dental procedures, with no mention of AI or ML in the description or performance studies.
No.
The device is used for temporary retraction and hemostasis of the gingival margin during dental procedures, which are temporary actions and not for treating a disease or condition.
No.
The device description and intended use clearly state that Giraffe2 is a paste containing a hemostatic agent for temporary retraction and hemostasis of the gingival margin, and is a "tissue management solution" for sulcular expansion. Its purpose is to physically manage tissue and stop bleeding during dental procedures, not to diagnose any condition or disease.
No
The device is described as a paste containing a hemostatic agent, which is a physical substance applied during dental procedures. This clearly indicates it is a physical medical device, not software.
Based on the provided information, Giraffe2 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use of Giraffe2 is for temporary retraction and hemostasis of the gingival margin during dental procedures. This is a direct application to the patient's tissue for a therapeutic or procedural purpose.
- Device Description: The description reinforces its use as a tissue management solution applied directly to the gingival sulcus.
- Lack of Diagnostic Purpose: IVD devices are used to examine specimens (like blood, urine, tissue samples) outside the body to provide information for diagnosis, monitoring, or screening. Giraffe2 does not involve the analysis of any biological specimen for diagnostic purposes.
- Anatomical Site: The anatomical site is the gingival margin, which is a direct application site on the patient.
In summary, Giraffe2 is a medical device used in vivo (on the living body) for a procedural purpose, not an in vitro diagnostic test performed on a specimen.
N/A
Intended Use / Indications for Use
Giraffe2 is a paste containing a hemostatic agent which is intended to be used for the temporary retraction and hemostasis of the gingival margin during dental procedures such as, but not limited to, dental impressions, seating of temporary and permanent restorations, restorations of cavities and placement of a rubber dam.
Product codes
MVL
Device Description
Giraffe2 is a paste containing a hemostatic agent which is intended to be used for the temporary retraction and hemostasis of the gingival margin during dental procedures such as, but not limited to, dental impressions, seating of temporary and permanent restorations, restorations of cavities and placement of a rubber dam. Girgffe2 is a tissue management solution that allows clinicians to quickly and easily obtain sulcular expansion in clinical situations prior to an impression. Additionally, Giroffe2 will help stop bleeding and prevent the flow of crevicular fluid upon removal, further assuring accurate and complete impressions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gingival margin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinicians / dental procedures
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility studies have been completed on Giraffe2, which demonstrate that the material is safe for its intended use. This 510(k) submission also includes data from bench testing used to evaluate the physical properties of Girgffe2 compared to the predicate device, Expa-syl.
Based upon the biocompatibility and bench testing, the clinical performance of Girgffe2 is deemed to be substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Expa-syl
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0